FDA Inspection
Assut Europe S.p.A.Assut Europe S.p.A. – FDA Inspection, Sep 26, 2024
Record Details
This FDA Inspection record concerns Assut Europe S.p.A., with an inspection on September 26, 2024, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · 1e4cd9a3-974e-483c-87e4-187e03dcb3b8
Inspection Facts
Official Action Indicated (OAI)
Significant objectionable conditions were found and regulatory or administrative action is recommended.
- Inspection number
- 1244235
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Medical Devices
- Outcome
- Form 483 issued
FDA Citations
7- 21 CFR 820.40Procedures not adequately established or maintained
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.80(d)Lack of or inadequate final acceptance procedures
- 21 CFR 820.75(b)Lack/Inad procedure-Monitoring/Control of Validated Proces
- 21 CFR 820.198(a)Lack of or inadequate complaint procedures
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
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Other FDA inspections of Assut Europe S.p.A.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| January 11, 2018 | VAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
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